The Israeli Society for the Prevention of Heart Attacks (ISPHA), a non-profit organization supervised by the Israel Ministry of Health is located at the Neufeld Cardiac Research Institute, Sheba Medical Center, Tel Hashomer. It specializes in the coordination of multi-center trials and surveys in a wide variety of fields of cardiac research, bringing together up to 26 cardiac centers.

Medical Director, Coordinating Center: Prof. Solomon Behar, M.D.

Head, Epidemiology and Biostatistics Unit: Prof. Uri Goldbourt, Ph.D.

Statistical Quality Control and Computing Advisor: Prof. Mitchell Snyder, Ph.D.

Investigators:
Henrietta Reicher - Reiss, M.D.
Avraham Shotan, M.D.
Shmuel Gottlieb, M.D.
Michal Benderly, M.Sc.
Valentina Boyko, M.Sc.
Lori Mandelzweig, MPH



The Center specializes in design, implementation, monitoring, computerization and analysis of controlled large magnitude multi-center clinical trials, as well as:

  • Independent performance of full-scale Israeli surveys

  • Cooperation in International Surveys, from the Israeli aspect of an international multi-center clinical trial.

  • Data processing, interpretation for large surveys conducted by other organizations / companies, or by local branches of international research groups


The Center supervises the full range of clinical trials in cardiology and any medical specialty, including:

  • U.S. Food and Drug Administration (FDA) trials

  • Primary and secondary prevention studies

  • Large-scale surveys examining the characteristics and prognosis of CHD and other illness

  • Phase 2 and 3 clinical trials

  • Multi-center international surveys and studies, data management and analysis

  • Data processing and interpretation of data gathered in surveys performed by other organizations and companies.



ISPHA's Coordinating Center is one of a few centers in the world which can steer you through translation of a clinical scientific issue, design and performance of the study, to collection, editing and final analysis and write-up of the results.

Our facility includes:

  • Compiling of complex study protocols and preparing case record forms
  • Full range of clinical investigations (patients, testing, biochemical exams)
  • Central laboratory organization for uniformity
  • Extensive experience in shipping specimens
  • Study monitoring by CRA
  • Quality data entry
  • Online tailored data entry interfaced with extensive logical checks and data validation to enhance error-free data entry
  • Computer monitoring, periodical examination of the data entered
  • Automated data transfer from any laboratory / participating center to study computer center



With over 20 years experience and up to 26 participating medical centers, the ISPHA and its Coordinating Center, has the tools and experience in statistical analysis to readily produce results. Participating hospitals maintain affiliations with leading university medical schools and benefit from their location in Israel, a world-leading center of medical, scientific and technological research that has gained an international reputation for excellence. Among the cutting-edge computer capabilities and facilities available for our trials are:
  • SAS/STAT statistical software including many tailor made macros for data entry, table generation and advanced statistical analyses
  • Publication quality graphics embedded in papers



The scientific and steering committee members of the research projects include the directors of cardiology departments in Israel, that are all related to major institutions of higher education, including the Tel Aviv University, The Technion – Israel Institute of Technology, The Hebrew University of Jerusalem, and the Ben-Gurion University of the Negev.


The Coordinating Center has vast experience in problem solving in different phases of controlled clinical trials. The existence of the collaborative framework in Israel has, over the last decade, facilitated surveys on unstable angina and its frequency in Israeli hospitals, two nationwide surveys of myocardial infarction-related hospitalizations, a survey on nationwide policies of thrombolysis and additional initiatives. Among the wide range of trials performed for pharmaceutical companies are:
  • The SPRINT Study (Secondary Prevention Reinfarction Israeli Nifedipine Trial) – the first large-scale clinical trial organized by the Coordinating Center in 1981. 2276 patients were recruited from 14 Israeli hospitals to examine the effect of nifedipine, a dihydropyridine calcium antagonist, to patients discharged from hospital after acute myocardial infarction. Cooperation between a significant number of coronary care units and heart institutes in Israel laid the foundation for continued collaborative efforts. Followed by SPRINT II – a study of nifedipine, a calcium antagonist, to track late administration of the drug to patients discharged after myocardial infarction proved safe but ineffective.
  • BIP (Bezafibrate Infarction Prevention) Study synchronized 18 cardiac institutions, in a placebo-controlled multi-center trial with 3122 participants, all CHD patients. The study aimed to investigate the efficacy of bezafibrate, a drug that reduces the blood levels of triglycerides and fibrinogen and elevates those of HDL cholesterol. By virtue of its size, multiplicity of centers and its length, beginning in 1990 and continuing through 2000, the study was a major challenge and included all activities from compilation of the protocol to detailed statistical analysis. Some 16,000 patients were screened over a period of 2 years and 3122 were recruited to the study.
  • ARGAMI-2 – an investigation of Argatroban in myocardial infarction – commenced in 1996 and was conducted in all of the 25 coronary care units in Israel. This multi-center randomized study aimed to compare the efficacy and safety of Argatroban versus heparin in patients undergoing thromboysis with TPA or streptokinase. A detailed database, including anamnestic data, findings from physical examinations and laboratory data was established for the entire population of 5,000 patients with acute myocardial infarction who were screened.
  • PRINCESS (PRevention of re-Infarction by early treatment of CErivaStatin Study) was a multinational randomized trial designed to determine whether early acute treatment with cerivastatin after a myocardial infarction would reduce the incidence of cardiovascular morbidity and mortality. During one year of recruitment, initiated in August 2000 and terminated in August 2001, ~3600 patients from 14 countries were included in the study. Data collected in 333 centers were transferred to the Coordinating Center, which was responsible for all data management, including checking of forms, double data entry and quality assurance, as well as tracking and management of critical events and serious adverse events.



Taking advantage of the screening of patients for these trials, the center has compiled several large registries of thousands of screened patients in the areas of acute myocardial infarction, lipid and lipoprotein assessment and more, all available for use in future research and study.


From1990, and bi-annually thereafter, nationwide surveys have been conducted in all Israeli CCU's during the months of January and February. These surveys assess the characteristics, management and outcome of AMI patients with specific emphasis on use of thrombolytic therapy and revascularization procedures.
A survey on acute coronary syndrome was conducted in February-March, 2000, in all CCU’s and many internal medicine wards in the country to assess the variation in therapeutic modalities between the hospitals for this very common admission diagnosis in our country.